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Safety and Efficacy of a Pentavalent Human– Bovine (WC3 ... - PATH

Safety and Efficacy of a Pentavalent Human– Bovine (WC3 ... - PATH

Safety and Efficacy of a Pentavalent Human– Bovine (WC3 ... -

The new england journal of medicine original article Safety and Efficacy of a Pentavalent Human– Bovine (WC3) Reassortant Rotavirus Vaccine Timo Vesikari, M.D., David O. Matson, M.D., Ph.D., Penelope Dennehy, M.D., Pierre Van Damme, M.D., Ph.D., Mathuram Santosham, M.D., M.P.H., Zoe Rodriguez, M.D., Michael J. Dallas, Ph.D., Joseph F. Heyse, Ph.D., Michelle G. Goveia, M.D., M.P.H., Steven B. Black, M.D., Henry R. Shinefield, M.D., Celia D.C. Christie, M.D., M.P.H., Samuli Ylitalo, M.D., Robbin F. Itzler, Ph.D., Michele L. Coia, B.A., Matthew T. Onorato, B.S., Ben A. Adeyi, M.P.H., Gary S. Marshall, M.D., Leif Gothefors, M.D., Dirk Campens, M.D., Aino Karvonen, M.D., James P. Watt, M.D., M.P.H., Katherine L. O’Brien, M.D., M.P.H., Mark J. DiNubile, M.D., H Fred Clark, D.V.M., Ph.D., John W. Boslego, M.D., Paul A. Offit, M.D., and Penny M. Heaton, M.D., for the Rotavirus Efficacy and Safety Trial (REST) Study Team abstract background Rotavirus is a leading cause of childhood gastroenteritis and death worldwide. methods We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human–bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events. results The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1–G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1–G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1–G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent). conclusions This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.) From the University of Tampere Medical School, Tampere, Finland (T.V., S.Y., A.K.); the Center for Pediatric Research, Eastern Virginia Medical School, Norfolk (D.O.M.); the Division of Pediatric Infectious Diseases, Rhode Island Hospital, Providence (P.D.); the Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium (P.V.D.); the Center for American Indian Health, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore (M.S., J.P.W., K.L.O.); the University of Puerto Rico School of Medicine, San Juan (Z.R.); Merck Research Laboratories, West Point, Pa. (M.J. Dallas, J.F.H., M.G.G., R.F.I., M.L.C., M.T.O., B.A.A., M.J. DiNubile, J.W.B., P.M.H.); Kaiser Permanente Vaccine Study Center, Oakland, Calif. (S.B.B.); the Institute of Vaccine and Pharmacologic Research in San Francisco, San Francisco (H.R.S.); the Department of Pediatrics, University of the West Indies, Kingston, Jamaica (C.D.C.C.); the Department of Pediatrics, University of Louisville School of Medicine, Louisville, Ky. (G.S.M.); the Department of Clinical Sciences Pediatrics, Umea University, Umea, Sweden (L.G.); Sanofi Pasteur Merck, Sharp & Dohme, Lyon, France (D.C.); and Children’s Hospital and the University of Pennsylvania School of Medicine, Philadelphia (HF.C., P.A.O.). Address reprint requests to Dr. Heaton at Merck Research Laboratories, P.O. Box 4, UNC-151, West Point, PA 19486, or at penny_heaton@ merck.com. N Engl J Med 2006;354:23-33. Copyright © 2006 Massachusetts Medical Society. n engl j med 354;1 www.nejm.org january 5, 2006 23

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